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DOSAGE - INJECTABLE;INJECTION - EQ 1GM BASE/V...DOSAGE - INJECTABLE;INJECTION - EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50679
DOSAGE - INJECTABLE;INJECTION - EQ 2GM BASE/V...DOSAGE - INJECTABLE;INJECTION - EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50679
DOSAGE - INJECTABLE;INJECTION - EQ 500MG BASE...DOSAGE - INJECTABLE;INJECTION - EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50679
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ABOUT THIS PAGE
A Cefepime Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cefepime Hydrochloride, including repackagers and relabelers. The FDA regulates Cefepime Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cefepime Hydrochloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Cefepime Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cefepime Hydrochloride supplier is an individual or a company that provides Cefepime Hydrochloride active pharmaceutical ingredient (API) or Cefepime Hydrochloride finished formulations upon request. The Cefepime Hydrochloride suppliers may include Cefepime Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Cefepime Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cefepime Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Cefepime Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Cefepime Hydrochloride DMFs exist exist since differing nations have different regulations, such as Cefepime Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cefepime Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Cefepime Hydrochloride USDMF includes data on Cefepime Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cefepime Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cefepime Hydrochloride suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Cefepime Hydrochloride Drug Master File in Japan (Cefepime Hydrochloride JDMF) empowers Cefepime Hydrochloride API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Cefepime Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Cefepime Hydrochloride JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Cefepime Hydrochloride suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Cefepime Hydrochloride Drug Master File in Korea (Cefepime Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Cefepime Hydrochloride. The MFDS reviews the Cefepime Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Cefepime Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Cefepime Hydrochloride KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Cefepime Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Cefepime Hydrochloride suppliers with KDMF on PharmaCompass.
A Cefepime Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Cefepime Hydrochloride Certificate of Suitability (COS). The purpose of a Cefepime Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cefepime Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cefepime Hydrochloride to their clients by showing that a Cefepime Hydrochloride CEP has been issued for it. The manufacturer submits a Cefepime Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cefepime Hydrochloride CEP holder for the record. Additionally, the data presented in the Cefepime Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cefepime Hydrochloride DMF.
A Cefepime Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cefepime Hydrochloride CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Cefepime Hydrochloride suppliers with CEP (COS) on PharmaCompass.
A Cefepime Hydrochloride written confirmation (Cefepime Hydrochloride WC) is an official document issued by a regulatory agency to a Cefepime Hydrochloride manufacturer, verifying that the manufacturing facility of a Cefepime Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cefepime Hydrochloride APIs or Cefepime Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Cefepime Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Cefepime Hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Cefepime Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cefepime Hydrochloride API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Cefepime Hydrochloride as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Cefepime Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cefepime Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cefepime Hydrochloride suppliers with NDC on PharmaCompass.
Cefepime Hydrochloride Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Cefepime Hydrochloride GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Cefepime Hydrochloride GMP manufacturer or Cefepime Hydrochloride GMP API supplier for your needs.
A Cefepime Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Cefepime Hydrochloride's compliance with Cefepime Hydrochloride specifications and serves as a tool for batch-level quality control.
Cefepime Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Cefepime Hydrochloride CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Cefepime Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Cefepime Hydrochloride EP), Cefepime Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cefepime Hydrochloride USP).
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